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PREVENTION OF DIABETIC FOOT ULCERS AND LOWER EXTREMITY AMPUTATION Barry Stults, M.D. Scott Clark, D.P.M Thomas Miller, M.D. University of Utah Medical.

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1 PREVENTION OF DIABETIC FOOT ULCERS AND LOWER EXTREMITY AMPUTATION Barry Stults, M.D. Scott Clark, D.P.M Thomas Miller, M.D. University of Utah Medical Center ©2006. American College of Physicians. All Rights Reserved.

2 CASE: Mr. M.C. 64 yr-old obese white male, not seen x 12 mo Type 2 DM (15 yrs) BP  (18 yrs) Dyslipidemia(18 yrs) CABG(10 yrs ago) Claudication(today; 25 yds) Insulin/Metformin/Statin/ARB/Hctz/CCB/ASA “Sore on my left foot, Doc” ©2006. American College of Physicians. All Rights Reserved.

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4 CASE: Mr. M.C. Clinical evaluation of heel ulcer: –Probe reached bone –Extensive subcutaneous abscess MRI: extensive osteomyelitis ABI: 0.2 Angiography: severe infrapopliteal, suprapopliteal obstruction –Not amenable to revascularization Uncontrolled infection despite antibiotics/drainage ©2006. American College of Physicians. All Rights Reserved.

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6 AMPUTATIONS IN DIABETES Common: Worldwide – amputation 2  to diabetes q 30 sec. U.S.A. – 80,000 amputations/y (2002) –Higher rates in men, racial/ethnic minorities Costly: $60,000/amputation $2 billion/y total costs Lancet 2005; 366:1719Diabetes Care 2004; 27:1598 Diabetes Care 2003; 26:495 ©2006. American College of Physicians. All Rights Reserved.

7 AMPUTATIONS IN DIABETES Tragic: “Rule of 50” 50% of amputations transfemoral/transtibial level 50% of patients 2 nd amputation in  5y 50% of patients Die in  5y Clinical Care of the Diabetic Foot, 2005 ©2006. American College of Physicians. All Rights Reserved.

8 FOOT ULCERS IN DIABETES Precipitate 85% of amputations: “Rule of 15” 15% of diabetes patientsFoot ulcer in lifetime 15% of foot ulcersOsteomyelitis 15% of foot ulcersAmputation Clinical Care of the Diabetic Foot, 2005 ©2006. American College of Physicians. All Rights Reserved.

9 FOOT ULCERS IN DIABETES Costly: $30,000/ulcer $9 billion/y total costs Tragic: Quality of life: ulcer patient  amputation patient –Burden of non-weight-bearing as ulcer heals –Lifetime behavioral adaptations to prevent recurrence –Fear of recurrent ulcer/amputation 70% ulcer recurrence in  3y Foot Ankle Int 2005; 26:32, 128 Clin Infect Dis 2004; 39(Suppl 2):S129 ©2006. American College of Physicians. All Rights Reserved.

10 TEAM CARE REDUCES ULCERS/AMPUTATIONS Five clinical trials: Format: integrated, risk-stratified interventions –ID high-risk patients with exam: Frequent follow-up to detect early problems Educate/motivate self-care behaviors Prophylactic nail/skin care by podiatry Therapeutic footwear, if needed –Prompt, multidisciplinary Rx of ulcers Lancet 2005; 366:1676 ©2006. American College of Physicians. All Rights Reserved.

11 TEAM CARE REDUCES ULCERS/AMPUTATIONS Efficacy of team care: –50-80% reductions in ulcers/amputations Economic modeling studies of team care: –Cost-effective if 25-40% reduction in ulcer rate –Cost-saving if > 40% reduction in ulcer rate Applicable only to high-risk patients Lancet 2005; 366:1719Diabetes Care 2004; 27:901 ©2006. American College of Physicians. All Rights Reserved.

12 Sensory  Joint Motor Autonomic PAD Neuropathy Mobility Neuropathy Neuropathy  Protective Muscle atrophy and  Sweating Ischemia sensation 2° foot deformities2° dry skin  Foot pressure  Foot pressure Fissure  Healing  Minor trauma esp. over recognition bony prominences Callus Pre-ulcer ULCER Infection AMPUTATION Minor Trauma: Interdigital Maceration Mechanical (Moisture, Fungus) Chemical Thermal PATHOGENESIS OF DIABETIC FOOT ULCER AND AMPUTATION ©2006. American College of Physicians. All Rights Reserved.

13 OTHER RISKS FOR ULCER/AMPUTATION Failure to adequately care for the feet: –Inadequate patient education –Inadequate patient motivation Depression, anxiety, anger more common in diabetes –Physical disability Cannot see feet 2  to retinopathy Cannot reach feet 2  to obesity, age (?50% of patients) –Limited access to podiatry services Age Ageing 1992; 21:333 Diabetes Care 2003; 29:495 Diab Metab Res Rev 2004; 20(Suppl 1):S13 ©2006. American College of Physicians. All Rights Reserved.

14 CAUSAL PATHWAYS FOR FOOT ULCERS % Causal Pathways NEUROPATHYNeuropathy: 78%  Minor trauma:79% DEFORMITYDeformity:63%  Behavioral issues ? MINOR TRAUMA - Mechanical (shoes)POOR SELF- - ThermalFOOT CARE - Chemical ULCER Diabetes Care 1999; 22:157 ©2006. American College of Physicians. All Rights Reserved.

15 DETECTING FEET-AT-RISK History: –Prior amputation –Prior foot ulcer –PAD: known or claudication at < 1 block Exam: –Insensate to 5.07/10g monofilament –Major foot deformities –PAD Absent DP and PT pulses Prolonged venous filling time Reduced Ankle-Brachial Index (ABI) –Pre-ulcerative cutaneous pathology Arch Intern Med 1998; 158:157 ©2006. American College of Physicians. All Rights Reserved.

16 RISK STRATIFY FOR FOOT ULCERATION Foot Ulcer, % Office Patients Risk Level %/yr (diabetes clinics) 3: prior amputation 28.1% 7% prior ulcer 18.6% 2: insensate 6.3% 10% and foot deformity or absent pedal pulses 1: insensate 4.8% % 0: all normal 1.7% 66% Diabetes Care 2001; 24:1442Diabetes Metab 2003; 29:261 ©2006. American College of Physicians. All Rights Reserved.

17 ANNUAL DIABETIC FOOT EXAMS 2000 Behavioral Risk Factor Surveillance System, CDC Total Private Insurance Medicaid- MedicareVAUninsured % with foot exam in past year *48* *p < 0.01 Health Services Research 2005; 40:361 ©2006. American College of Physicians. All Rights Reserved.

18 PHYSICAL EXAMINATION OF THE FEET IN PERSONS WITH DIABETES ©2006. American College of Physicians. All Rights Reserved.

19 SENSORY NEUROPATHY IN DIABETES Loss of protective sensation in feet –Sensory loss sufficient to allow painless skin injury Major risk factor for foot ulcer in diabetes Detect with 5.07/10g Semmes-Weinstein monofilament –Prevalence of insensate feet to 10g monofilament: Age > 40y: 30% of diabetic patients Age > 60y: 50% of diabetic patients Up to 50% have no neuropathic symptoms Diabetes Care 2006; 29(Suppl 1):S24Diabetes Care 2004; 27:1591 ©2006. American College of Physicians. All Rights Reserved.

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22 UTILITY OF MONOFILAMENT TESTING Predicts ulcer/amputation in 5 prospective studies: NPV (normal sensing) = 90-98% PPV (fail to sense) = 18-36% Prospective 32 mo observational study: –80% of ulcers/100% of amputations in insensate feet Superior predictive value to other tests: –Pin prick, cotton wisp, symptoms –? 128 Hz tuning fork? ADA recommendation, 2006: also test vibration Diabetes Care 2006; 29(Suppl 1):S25 J Fam Pract 2000; 49:S30 Diabetes Care 1992; 15:1386 ©2006. American College of Physicians. All Rights Reserved.

23 USING THE 5.07/10gm MF (Tool-Kit) Demonstrate sensation on the forearm or hand Place monofilament perpendicular to test site Bow into C-shape for one second Test four sites/foot: Predicts 95% of ulcer formers vs. 8 sites Heel testing does not discriminate ulcer formers Avoid calluses, scars, and ulcers ©2006. American College of Physicians. All Rights Reserved.

24 USING THE 5.07/10g MF (Tool-Kit) Minimize bias: –Test sites in random sequences –Test each site X3, sham test as 1 of 3 Do you feel it? Yes or No? Retest site if patient fails (misses 2/3 responses) Insensate at 1 site = insensate feet Falsely insensate with edema, cold feet Test annually when sensation normal Use < 100x/d; replace if bent; replace q 3 mo. Purchase calibrated MF (See Tool-Kit) ©2006. American College of Physicians. All Rights Reserved.

25 PAD IN DIABETES Prevalence (ABI < 0.9): 20-30% –10-20% in type 2 diabetes at Dx –30% in diabetics  age 50y –40-60% in diabetics with foot ulcer Complications: –Claudication and functional disability –Increases risk for concurrent CAD and CVD –Delays ulcer healing Increases amputation risk Not increase foot ulcer risk JACC 2006; 47:921 Diabet Med 2005; 22:1310 Diabetes Care 2003; 26:3333 ©2006. American College of Physicians. All Rights Reserved.

26 HX TO DETECT PAD IN DIABETES Claudication at < 1 block suggests severe ischemia Vascular LevelSite of Pain Aorto-iliacButtocks/Thigh FemoralCalf TibioperonealFoot/Ankle Rest painindicates critical ischemia –Toes and forefoot –Difficult to distinguish from neuropathic pain ©2006. American College of Physicians. All Rights Reserved.

27 (After Pompogelli and Campbell, 2002) Ischemic Rest Pain Unilateral (usually) Continuous;  hs  With dependency Absent DP/PT pulses Neuropathic Pain Bilateral (usually) Wax/wane No change with dependency Variable DP/PT pulses HX TO DETECT PAD IN DIABETES ©2006. American College of Physicians. All Rights Reserved.

28 HX TO DETECT PAD IN DIABETES Asymptomatic, severe PAD common in diabetes –Tibio-peroneal disease predominance: Unrecognized ankle/foot claudication No claudication –Sensory neuropathy blunts/eliminates pain sensation of claudication and rest pain Diabetes Care 2003; 26:3333 ©2006. American College of Physicians. All Rights Reserved.

29 EXAM TO DETECT PAD IN DIABETES Pedal pulse exam: –Absent DP and PT: LR = for severe PAD –Absent DP or PT not predict PAD Non-palpable DP (8%) or PT (3%) in normals –Present DP and PT not R/O PAD! 30% with PAD have one palpable pulse (collaterals) High PAD suspicion  vascular testing –Claudication, foot ulcer JAMA 2006; 295:536 Arch Intern Med 1998; 158:1357Diabetes Care 2003; 26:3333 ©2006. American College of Physicians. All Rights Reserved.

30 EXAM TO DETECT PAD IN DIABETES Venous filling time –Technique: Sitting: ID pedal vein bulging above skin Supine: Elevate leg to 45° for 1 min Sitting: time to pedal vein bulging above skin J Clin Epidemiol 1997; 50:659Arch Intern Med 1998; 158:1357 ©2006. American College of Physicians. All Rights Reserved.

31 EXAM TO DETECT PAD IN DIABETES Venous filling time –Filling time > 20 sec predicts ABI < 0.5 Sensitivity = 22%; Specificity = 94%; LR = 3.9 J Clin Epidemiol 1997; 50:659 Arch Intern Med 1998; 158:1357 ©2006. American College of Physicians. All Rights Reserved.

32 OTHER EXAM FINDINGS FOR PAD Helpful: –Femoral bruit (  LR = 4.7–5.7) –Unilateral cool extremity Not predictive of PAD: –Atrophic skin –Hair loss –Capillary refill > 5 sec Diabetes Med 2005; 22:1310Arch Intern Med 1998; 158:1357 ©2006. American College of Physicians. All Rights Reserved.

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34 VASCULAR LAB TO DETECT PAD Ankle/Brachial BP Index or ABI Testing –Screening: 2004 ADA recommendation “Consider” at age 50 and q 5 yr Screen earlier if multiple CVD risks –Diagnosis: Claudication, absent DP/PT pulses, foot ulcer –Limitations: Underestimate severity if medial artery Ca ++ Consider pulse volume recording, systolic toe BP, vascular consultation if uncertain about PAD Diabetes Care 2005; 28:2206 Diabetes Care 2004; 27(Suppl 1): S15-S35 ©2006. American College of Physicians. All Rights Reserved.

35 INTERPRETATION OF THE ABI ABI Normal Mild obstruction *Moderate obstruction *Severe obstruction  0.40 **Poorly compressible>1.30 2° to medial Ca ++ *Poor ulcer healing with ABI  0.50 **Further vascular evaluation needed ©2006. American College of Physicians. All Rights Reserved.

36 MOTOR NEUROPATHY AND FOOT DEFORMITIES Hammer toes Claw toes Prominent metatarsal heads Hallux valgus Collapsed plantar arch ©2006. American College of Physicians. All Rights Reserved.

37 From Levin and Pfeifer, The Uncomplicated Guide to Diabetes Complications, 2002 Hammer Toes Claw Toes ©2006. American College of Physicians. All Rights Reserved.

38 From Levin and Pfeifer, The Uncomplicated Guide to Diabetes Complications, 2002 Hallux Valgus ©2006. American College of Physicians. All Rights Reserved.

39 From Boulton, et al Diabetic Medicine 1998, 15:508 ©2006. American College of Physicians. All Rights Reserved.

40 PRE-ULCER CUTANEOUS PATHOLOGY Neuropathy  inappropriate footwear: –Persistent erythema after shoe removal –Callus –Callus with subcutaneous hemorrhage: “pre-ulcer” Autonomic neuropathy and secondary dry skin: –Fissure  ulceration –Augment callus formation Poor self-care of the feet: –Interdigital maceration with fungal infection –Nail pathology ©2006. American College of Physicians. All Rights Reserved.

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57 RISK-STRATIFIED FOOTCARE MANAGEMENT FOR DIABETES PATIENTS ©2006. American College of Physicians. All Rights Reserved.

58 LOW RISK: CATEGORY 0 PATIENTS Annual comprehensive foot examination –Questionnaire completed by patient in waiting room –Examination form with decision-support (See Tool-Kit) Every visit visual inspection if higher risk –Racial/ethnic minorities; alcoholism; homeless Basic education: self-management, appropriate footwear –Brief counseling –Written handout JAMA 2005; 293:217 ©2006. American College of Physicians. All Rights Reserved.

59 HIGH RISK: CATEGORY 1-3 PATIENTS Annual comprehensive foot exam Inspect feet at every office visit Podiatry care stratified to risk level Intensive patient education Detect/manage barriers to foot care Therapeutic footwear, if needed ©2006. American College of Physicians. All Rights Reserved.

60 HIGH RISK: CATEGORY 1-3 PATIENTS Nursing tasks to facilitate foot exams: –“High Risk Feet” stickers to each chart (Tool-Kit) –Remove patient’s shoes/socks Increases % of foot exams in observational studies –Determine that patient can reach/see soles of feet –Stock 10g monofilament in each room Consider training to perform 10g monofilament exam –Provide patient education forms Literacy/language appropriate Diabetes Care 1983; 6:499 J Gen Intern Med 2003; 18:258 ©2006. American College of Physicians. All Rights Reserved.

61 ©2006. American College of Physicians. All Rights Reserved.

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63 HIGH RISK: CATEGORY 1-3 PATIENTS Regular prophylactic podiatry care: –Provide nail and skin care –Assess footwear needs –RCT: 48% RRR for recurrent ulceration –Optimal visit frequency not evidence-based: Category 1  q 3-6 mo Category 2  q 2-3 mo Category 3  q 1-2 mo Diabetes Care 2003; 26:1691 J Fam Practice 2000; 49(Suppl):S30 ©2006. American College of Physicians. All Rights Reserved.

64 HIGH RISK: CATEGORY 1-3 PATIENTS Intensive patient education: –1  care clinician, podiatrist, educator contribute –Reinforce frequently – low retention documented –Patient to demonstrate self-care knowledge Questionnaires, tests are available (see Tool-Kit) –Utility: ? Reduced foot ulcer/amputation rates? Cochrane Database Syst Rev 2005 Jan 25;(1)CD001488Foot Ankle Int 2005; 26:38 ©2006. American College of Physicians. All Rights Reserved.

65 BASIC FOOT CARE CONCEPTS Daily foot inspection –May require mirror, magnification, or caregiver –Educate patient to recognize/report ASAP: Persistent erythema Enlarging callus Pre-ulcer (callus with hemorrhage) ©2006. American College of Physicians. All Rights Reserved.

66 BASIC FOOT CARE CONCEPTS Commitment to self-care: –Wash/dry daily Avoid hot water; dry thoroughly between toes –Lubricate daily (not between toes) –Debride callus/corn to reduce plantar pressure 25% Avoid sharp instruments, corn plasters –No self-cutting of nails if: Neuropathy, PAD, poor vision ©2006. American College of Physicians. All Rights Reserved.

67 BASIC FOOT CARE CONCEPTS Protective behaviors: –Avoid temperature extremes –No walking barefoot/stocking-footed –Appropriate exercise if sensory neuropathy Bicycle/swim > walking/treadmill –Inspect shoes for foreign objects –Optimal footwear at all times ©2006. American College of Physicians. All Rights Reserved.

68 FOOT CARE EDUCATION TOOLS “Prevent diabetes problems: Keep your feet and skin healthy”  Cartoons – minimal text – still simple  or “Take Care of Your Feet For a Lifetime” – booklet  Few cartoons – more advanced  “Take Care of Your Feet For a Lifetime” – 1 page summary  ©2006. American College of Physicians. All Rights Reserved.

69 FOOT CARE EDUCATION TOOLS “Diabetic Foot Care” –American Orthopedic Foot and Ankle Society –Multilingual translation Available in 20 languages –Reference: Trepman E, et al. Foot and Ankle International 2005; 26: ©2006. American College of Physicians. All Rights Reserved.

70 EDUCATIONAL DEFICIENCIES: HIGH RISK PATIENTS 558 high risk patients: Deficiency% Deficient Not inspect feet regularly50% Walk barefoot/stockings62% Seldom/never test water temp.40% Trim callus with sharp object48% Not know to call ASAP for foot ulcer58% Not know how to select footwear57% From GE Reiber, 2003 ©2006. American College of Physicians. All Rights Reserved.

71 BASIC FOOTWEAR EDUCATION Avoid: Pointed-toes Slip-ons Open-toes High heels Plastic Black color Too small Favor: Broad-round toes Adjustable (laces, buckles, Velcro) Athletic shoes, walking shoes Leather, canvas White/light colors ½” between longest toe and end of shoe Diabetes Self-Management 2005; 22:33 ©2006. American College of Physicians. All Rights Reserved.

72 THERAPEUTIC FOOTWEAR: GOALS Inappropriate footwear: –Contributes to 21-76% of ulcers/amputations Optimal footwear should: –Protect feet from external injury –Reduce plantar pressure, shock and shear forces –Accommodate, stabilize, support deformities –Suitable for occupation, home, leisure Diabetes Care 2004; 27:1832 Diab Metab Res Rev 2004; 20(Suppl1):S51 ©2006. American College of Physicians. All Rights Reserved.

73 THERAPEUTIC FOOTWEAR: COMPONENTS Padded socks (eg. CoolMax, Duraspun, others) –Cushion metatarsal heads, heels, and decrease plantar pressure –White, seamless, absorbent acrylic fibers Shoe inserts/insoles (closed-cell foam, viscoelastic) –Off-the-shelf –Custom-molded Therapeutic shoes –Extra-depth  extra-width –Rigid rocker outsoles –Custom-molded ©2006. American College of Physicians. All Rights Reserved.

74 FOOTWEAR RECOMMENDATIONS BY RISK LEVEL Low Risk (0)Proper style/fit, cushioned stock shoes  Sensation (1)Deep toe box shoes, cushioned insoles Callosities, ulcer HxExtra-depth stock shoes, custom-molded insole Severe deformities Custom-molded extra-depth shoes and insoles, rigid rocker outsoles Modified from The Foot in Diabetes, 2000, p.136 ©2006. American College of Physicians. All Rights Reserved.

75 THERAPEUTIC FOOTWEAR: EFFICACY Decreases plantar pressure 50-70% Uncertain reduction in ulcer rate: –1  prevention: no data –2  prevention: controversial reduction of ulcer recurrence Analytic/descriptive studiesdecreases ulcers 50-75% 2 RCTsno benefit Benefits vary with footwear use, risk level? –Severe foot deformity, prior toe/ray amputation? Diabetes Care 2004; 27:1774 ©2006. American College of Physicians. All Rights Reserved.

76 MEDICARE COVERAGE OF THERAPEUTIC FOOTWEAR Certify diabetic patient with foot-at-risk –1° care physician Prescribe therapeutic footwear –D.P.M., D.O., M.D. Prepare/fit therapeutic footwear –Pedorthist, orthotist, prosthetist, D.P.M. Foot Ankle Int 2005; 26:42 ©2006. American College of Physicians. All Rights Reserved.

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78 MEDICARE COVERAGE OF THERAPEUTIC FOOTWEAR Medicare pays 80% of payment amount allowed: Total Amount Amount Covered by AllowedMedicare Extra Depth shoes $132.00$ Custom-made shoes $396.00$ Diabetic Pre-fab Insoles $67.00$53.60 Diabetic Custom Insoles $67.00$ pair extra-depth shoes  3 pair insoles/y, or 1 pair extra-depth shoes with modification  2 pair insoles/y, or 1 pair custom-molded shoes  2 pair insoles/y ©2006. American College of Physicians. All Rights Reserved.

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